Line 166 speaks of approved labeling of regulated products. Which, if any, of the following would fall into this category:
1. The product is only marketed as a grandfathered (no NDA) drug product.
2. The product is marketed as a DESI-related product (no NDA).
3. The NDA was approved pre-l962 and the DESI review has not been completed for it (labeling includes the possibly effective box), e.g., Midrin.